Ticagrelor with or without Aspirinin High-Risk Patients after PCI

1. Ticagrelor with or without Aspirin
in High-Risk Patients after PCI

2. • Monotherapy with a P2Y12 inhibitor after a minimum period of dual antiplatelet therapy is an
emerging approach to reduce the risk of bleeding after percutaneous coronary intervention (PCI).
• Ticagrelor with Aspirin or Alone in High-Risk Patients after Coronary Intervention (TWILIGHT) trial to
test the hypothesis that in patients undergoing PCI who are at high risk for ischemic or hemorrhagic
complications and who have completed a 3-month course of dual antiplatelet therapy with ticagrelor
plus aspirin, continued treatment with ticagrelor monotherapy would be superior to ticagrelor plus
aspirin with respect to clinically relevant bleeding and would not lead to ischemic harm.

3. • Key exclusion criteria included
• presentation with ST-segment elevation myocardial
• infarction,
• cardiogenic shock,
• ongoing long-term treatment with oral anticoagulants, or
• contraindication to aspirin or ticagrelor.

4. • Follow-up was performed by telephone at 1 month after
randomization and in person at 6 and 12 months after
randomization.
• The primary end point was the first occurrence of BARC type 2,
3, or 5 bleeding between randomization and 1 year in a time-to-
event analysis.
• The key secondary end point was the first occurrence of death
from any cause, nonfatal myocardial infarction, or nonfatal
stroke in time-to-event analysis.

7. Results
Out of 9,006 patients selected for participation, 7,119 were randomly assigned in a 1:1
fashion at 3 months to either ticagrelor plus placebo or ticagrelor plus aspirin with an
intention-to-treat. The baseline demographic and clinical characteristics were very similar
between the two arms: the mean age was 65 years, women represented 24% of
participants, and the prevalence of diabetes and chronic kidney disease was
approximately 40% and 17%, respectively. Multivessel coronary artery disease was
prevalent in 63.9% of patients in the experimental arm, and 61.6% of those in the control
arm.

8. • The primary endpoint, bleeding events (BARC type 2, 3, or 5),
occurred in 7.1% of patients who received ticagrelor plus
aspirin, and 4.0% of those who received ticagrelor plus
placebo.
• Secondary endpoints, mainly ischemic events (including all-
cause death, non-fatal MI, or non-fatal stroke), occurred
similarly in the two arms: 3.9% in those who received
ticagrelor plus placebo, and 3.9% in those who received
ticagrelor plus aspirin.

9. DISCUSSION
• Transition to ticagrelor monotherapy after 3 months of DAPT in high-
risk patients who received a drug-eluting stent was associated with a
significant decrease in the incidence of bleeding events (44% lower
risk of BARC type 2, 3, or 5 bleeding).
• In this trial, there was no evidence of a higher risk of death,
myocardial infarction, or stroke among patients who received
ticagrelor monotherapy than among those who received
ticagrelor plus aspirin.